Substudies

In addition to the main study ONTARGET® and TRANSCEND® trials, 7 substudies were designed to examine different parameters of interest in CV protection:

1) The ABPM (ambulatory blood pressure monitoring) substudy (n=1,000) is assessing whether potential differences in prevention of CV outcomes can be explained by differences in 24 hour blood pressure control.

2) The Cardiac MRI substudy (n=350) is evaluating whether structural and functional cardiac parameters are associated with clinical outcomes.

3) The Arterial Stiffness substudy (n=284) is determining whether telmisartan, compared to placebo, reduces arterial stiffness and if this reduction correlates with patients’ clinical outcome.

4) The Erectile Dysfunction substudy (n=1,500) is assessing the prevalence of erectile dysfunction and evaluating whether it is related to cardiovascular risk factors and/or to drugs used to treat CVD.

5) The Blood Markers substudy (n=12,000) is identifying risk markers, including genetic markers, for various CV disorders.

6) The Oral Glucose Tolerance substudy (n=4,000) is investigating whether chronic AT1-blockade can improve glucose metabolism and delay the onset of type 2 diabetes.

7) The Health Economics substudy (n=7,000) is measuring the impact of telmisartan and ramipril therapy on resource usage, direct medical costs of treatment necessitated by clinical events requiring hospitalisation, and patients benefits (utility assessment).

Patient assignment from each of the main study arms to each substudy is as follows:

OnTarget Substudies

Yusuf S. Am J Cardiol. 2002;98(suppl):18A-26A
Unger T. Am J Cardiol. 2003;91(suppl):28G-34G.
Zimmerman M, Unger T. Expert Opin Pharmacother. 2004;5:1201-8.

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Cardiometabolism
Cardiometabolism